Cynthia Weber

Director of Food Safety Training and Curriculum

The Food Safety Modernization Act: General Requirements

Jun 5, 2024

The Food Safety Modernization Act (FSMA) is a U.S. law, written with the goal of reducing foodborne illnesses and deaths in the U.S. According to the CDC, an estimated 48 million people in the United States (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from preventable foodborne diseases. The goal of FSMA is to change the focus from reacting to foodborne illnesses to preventing them. The law includes preventive measures that food producers must take. 

The Food Safety Modernization Act Explained 

The FSMA rule applies to your company if you manufacture, process, pack or hold human or animal food for consumption in the United States. This applies to companies in the U.S. as well as international companies that export to the U.S. 

FSMA Requirements 

The Food Safety Modernization Act of 2011 (FSMA) is the most fundamental change to food safety regulations in over 70 years. Affecting every step of the supply chain, FSMA gives the FDA the power to prevent rather than react to food safety crises. FSMA expands the scope of the FDA’s oversight by increasing the frequency of inspections of food facilities, particularly those that are deemed to be high risk. FSMA also allows the FDA access to the records and food safety plans that are now required of all food facilities. 

Explore our updated and detailed guide on FSMA Requirements. 

PCQI Training 

The FSMA rule requires that certain activities be performed by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls. 

What is a PCQI? 

FSVP Explained 

FSVP stands for Foreign Supplier Verification Programs. It is part of the Food Safety Modernization Act (FSMA). The purpose of this rule is to ensure that foreign suppliers of human and animal food that will be consumed in the U.S. are meeting the same level of public health protection as those required under the other FSMA rules. Importers share responsibility with foreign suppliers to ensure the safety of food imported into the U.S. 

Learn more about FSVP in our detailed guide.

FSVP Training 

Registrar Corp offers the only online and self-paced course that includes the official FSPCA certificate. Learn the requirements of FSVP and how to write your FSVP. 

Learn about FSVP training

Related Courses 

Food Safety Training for Employees

Employee Food Safety Training  

FDA Food Safety Training Courses

FDA Online Training Courses


What are FSMA Preventive Controls? 

What is new and unique about the Preventive Controls Rule is that it focuses on preventing food safety incidents instead of reacting to them after they happen. It requires a food safety plan that includes preventive controls and the process controls you will find in traditional HACCP plans. 

They include Preventive Controls for: 

  • Process 
  • Food allergens 
  • Sanitation 
  • Supply chain 

How do I become FSMA certified? 

Companies subject to the FSMA rule must comply with the requirements, have FSMA-compliant Food Safety Plans written by a trained PCQI, and be prepared for an FDA inspection. Registrar Corp offers the FSPCA PCQI coursecurriculum and the course includes the FSPCA training certificate.

What is FSMA for animal food? 

FSMA applies to both human and animal food. The requirements are different. There is the well-known Human Food Rule and an Animal Food Rule which covers animal food, pet food, and animal feed. There are separate PCQI training courses for human and animal food. 


HACCP (Hazard Analysis and Critical Control Points) and HARPC (Hazard Analysis and Risk-Based Preventive Controls) are both food safety management systems that aim to prevent food safety hazards and ensure the safety of the food supply. While both systems use a risk-based approach, there are differences between the two. 

HACCP is a preventive system that identifies and controls hazards at critical control points in the food production process. It is primarily used in the manufacturing and processing of food products. 

HARPC, or the FSMA Food Safety Plan is a preventive system that focuses on identifying and controlling hazards throughout the entire food supply chain. FSMA requires companies to identify and control potential hazards throughout the entire production process, from raw materials to finished products. FSMA places greater emphasis on preventive controls that are designed to address potential hazards before they occur, rather than relying solely on monitoring and corrective actions. 


FSVP is a component of FSMA. The goal is to make sure that the food imported into the United States is as safe as food that is manufactured in the U.S.. Importers of the food are required to make sure that it is. FSVP applies to U.S. importers of food and beverage products, as well as certain types of food brokers and agents. 


Cynthia Weber

Director of Food Safety Training and Curriculum

Related Article

Subscribe To Our News Feed

To top
This site is registered on as a development site. Switch to a production site key to remove this banner.